Kornimate/medical-research-clean huggingface dataset:
clinical evaluation of the use of ginger extract in the management of motion sickness

Conditions: Motion Sickness

Summary: this is an open-label, case control study of 180 patients presenting motion sickness, who will perform a motion sickness assessment questionnaire before and after treatment with dry ginger (z. officinale) extract.

this open-label, self-paired, case-control study will evaluate 180 patients presenting motion sickness. the primary study objective is to evaluate the use of dry z. officinale extract 160mg (containing 8mg gingerol) in the treatment of patients presenting motion sickness. the secondary objectives are to evaluate the effect of the treatment on the scores and subscores of the motion sickness assessment questionnaire (msaq) before and after treatment, as well as to assess treatment tolerability in this population. the total study duration will be seven days. a total of four specific motion sickness assessments will be performed, one pre-treatment and three during the treatment period, which consists of an oral dose of 160mg ginger extract 30 minutes prior to the trip under evaluation.

Eligibility criteria:
inclusion criteria: * patients of both sexes between the ages of 18 and 65 * clinical presentation of motion sickness * female participant of reproductive age agrees to use birth control during study period * patient has read, understood, signed and dated informed consent document exclusion criteria: * hypersensitivity to any component of the study drug * history of biliary calculus * history of gastric irritation * hypertension \> 145 / 100mmhg * concomitant use of other medicinal products for the treatment of motion sickness

Keywords: zingiber officinale motion sickness motion sickness assessment questionnaire
the effect of renin angiotensin system blockage (ras) blockade on ptx3 levels in diabetic patients with proteinuria

Conditions: Diabetes; Proteinuria; Renin Angiotensin System

Summary: long pentraxin 3 (ptx3) is a recently discovered multimeric inflammatory mediator structurally linked to crp and serum amyloid p-component. there is no data about the effects of renin angiotensin system blockage (ras) on ptx3 levels in diabetic patients with proteinuria. the aim of this study was to find out whether the beneficial effects of ras blockage in diabetic proteinuria has any relation with the alteration of ptx3 levels. we searched for the effects of ace inhibitor ramipril on the clinical and laboratory parameters of diabetic patients with proteinuria.

the patients who were non-obese (bmi\<30kg/m2), non dyslipidemic (total cholesterol \<200mg/dl, triglyceride\<150mg/dl), and free of cardiovascular events (negative medical history, negative ecg findings) were investigated for enrollment. ckd stage 1 patients older than 18 years of age and willing to participate to the study were screened. from the 266 patients with established type 2 diabetes mellitus, 141 had proteinuria and/or hypertension (24 h protein excretion 1-2 g/day, systolic blood pressures ≥140mmhg and/or diastolic blood pressures ≥ 90 mmhg, respectively). all cases were first referrals and at the time of the study all were off treatment. patients with history of coronary artery disease, smokers and those taking statins or renin-angiotensin blockers were excluded because of the effect of these factors on endothelial dysfunction. of 141 screened patients 60 met the study criteria and were included in this study. the duration of proteinuria and diabetic nephropathy after initial diagnosis was not known. the exclusion criteria were as follows: a)nephrotic syndrome, b)coronary heart disease (patients with ischemic st-t alterations and voltage criteria for lvh on electrocardiogram, and with history of revascularization or myocardial infarction), c) elevated liver enzymes (ast or alt levels ≥ 40u/l) and d) renal failure (serum creatinine levels \> 1.3 mg/dl). in order to evaluate the effect of ras blockade on plasma ptx3 concentrations, patients with proteinuria were given an ace inhibitor (ramipril 5 mg/day) for 12 weeks. the effect of ras blockade on insulin sensitivity and proteinuria was also investigated. after the intervention period, blood samples were obtained for assay of plasma ptx3 concentrations, hba1c , and insulin resistance scores (homa-ir). urine samples were also collected over a 24-hour period to determine the degree of proteinuria.

Eligibility criteria:
inclusion criteria: * ckd stage 1 patients * older than 18 years of age * type 2 diabetic patients * proteinuria exclusion criteria: * history of coronary artery disease * smokers * taking statins or renin-angiotensin blockers

Keywords: ptx3, ramipril, endothelial dysfunction 1- diabetic proteinuria 2- the aim of this study was to find out whether the beneficial effects of ras blockage in diabetic proteinuria has any relation with the alteration of ptx3 levels.
vitamin d supplementation in hiv youth

Conditions: HIV Infections

Summary: the purpose of this study is to determine the correct dose of vitamin d to give to prevent hiv related complications.

the purpose of the this study was to compare control dose of vitamin d (low dose of 600 iu/d) to supplementation dose (medium dose of 2000 iu/d or higher doses of vitamin d of 4000 iu/d) on hiv-related comorbidities including immune activation, inflammation, cardiovascular diseases, and metabolic complications in hiv-infected youth.

Eligibility criteria:
inclusion criteria: * ages 8-25 * documented hiv-1 infection * on stable antiretroviral therapy for \> 3 months * cumulative antiretroviral therapy of at least 6 months * 25(oh)d level \< 30 ng/ml at screening exclusion criteria: * \> 400 iu daily regular vitamin d intake * parathyroid/calcium disorders * active malignancy * pregnancy/intent to become pregnant/breastfeeding * chronic infectious/inflammatory conditions * creatinine clearance \< 50 ml/min * hemoglobin \< 9.0 g/dl * aspartate aminotransferase and alanine aminotransferase \> 2.5 upper limit of normal * diabetes requiring hypoglycemic agents * known coronary artery disease * inability to swallow pills

Keywords: hiv vitamin d deficiency
nellix registry study: evas-global

Conditions: Abdominal Aortic Aneurysm

Summary: multicenter, single arm, open label, registry study with consecutive, eligible patient enrollment at each site. all subjects undergoing the endovascular aneurysm sealing system (evas) with the nellix®-system. subjects will be followed procedurally to discharge, and as per institutional standard of care thereafter through to 5 years (total follow-up commitment)


Eligibility criteria:
inclusion criteria: 1. male or female at least 18 years old 2. subject has signed informed consent for data release 3. subjects with with aaa and eligible for endovascular repair exclusion criteria: 1. currently participating in another study where primary endpoint has not been reached yet 2. known allergy to any of the device components 3. pregnant (females of childbearing potential only)

Keywords: aaa, aortoiliac aneurysm
treatment of anxiety disorders for children and adolescents in regular outpatient clinics

Conditions: Anxiety Disorders

Summary: the purpose of this study is to examine the content of the treatment being delivered for anxiety disorders for children and adolescents in the regular outpatient clinics in western norway. the study will also collect data before and after treatment to evaluate the result of the treatment. furthermore, as part of the study we aim to collect normative data on two questionnaires used to identify anxiety symptoms and the extent to which anxiety interfere with daily functioning. we also aim to develop a quality indicator for anxiety treatment that can be used to monitor treatment in the regular outpatient service, based on the results of the current study.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of an anxiety disorder (including ptsd and ocd) based on the diagnostic interview adis (adis-c/p; silverman \& albano, 1996). * the anxiety disorder is the patients primary diagnosis. * informed concent is given. exclusion criteria: * the patient is in need for other primary treatment intervention (e.g., psychosis, suicidality risk)

Keywords: anxiety children adolescent effectiveness outpatient
role of dietary protein on satiety, food intake and thermic effect of food

Conditions: Overweight; Obesity

Summary: objectives: to determine the effect of protein content of familiar breakfast meals on subjective appetite, food intake (fi), glycemic response and thermic effect of food (tef) in normal weight (nw) and overweight (ow)/obese (ob) children. specific objectives: 1a.to determine the effect of familiar breakfast meals (450 kcal containing eggs and varying in protein content (15, 30, and 45g) on subjective appetite, glycemic response and food intake at a test meal 4 h later in nw and. ow/ob children. 1b. to describe the effect of isocaloric (450 kcal) familiar breakfasts either high in protein (optimal protein from objective 1a) or low in protein on tef and substrate utilization over 5 h in nw and ow/ob children.

hypothesis: the investigators hypothesize that increasing the high-quality protein content of a breakfast meal will dose dependently increase subjective satiety, lower fi and glycemic response, and increase the tef in both nw and ow/ob children.

Eligibility criteria:
inclusion criteria: * boys and girls between the ages of 9 and 14 y * only peri-pubertal girls * normal body weight (between the 5th and 85th bmi percentile for age and gender) * ow/ob (\>85th bmi percentile for age and gender) exclusion criteria: * food sensitivities * food allergies * dietary restrictions * health, learning, emotional or behavioural problems * on any medication

Keywords: dietary protein satiety food intake thermic effect of food diet induced thermogenesis
family study of lymphoproliferative disorders

Conditions: Lymphoma, Non-Hodgkin; Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, B-Cell; Monoclonal B-Cell Lymphocytosis; Multiple Myeloma

Summary: blood and lymph node cancers can begin in either the lymphatic tissues (as in the case of lymphoma) or in the bone marrow (as with leukemia and myeloma), and they all are involved with the uncontrolled growth of white blood cells. there are many subtypes of these cancers, e.g., chronic lymphocytic leukemia and non-hodgkin lymphoma. since there is evidence that these cancers cluster in families, this study aims to understand how genetics and environmental exposures contribute to the development of these cancers.


Eligibility criteria:
at least 2 living, blood related relatives, affected with a lymphoproliferative disorder.
assessing glucose effects of sitagliptin (januvia) in adult patients with type 1 diabetes

Conditions: Type 1 Diabetes

Summary: the purpose of this study is to determine the effects of sitagliptin on glucose variability both after meals and overnight in adult patients with type 1 diabetes.

improved post prandial glucose control with multiple daily injections of insulin in the dcct study demonstrated significant reductions in microvascular complication. similar to type 2 diabetes, patients with type 1 diabetes have a paradoxical increase in glucagon after meals which contribute to worsening post prandial glucose control. this proposed study is designed to determine if altering the glucagon axis by giving sitagliptin can improve glucose control in patients with type 1 diabetes.

Eligibility criteria:
inclusion criteria: * male or female adult, aged 18 to 70 years * type 1 diabetes mellitus as established by medical history * current treatment with mdi or csii therapy for at least 3 months prior to screening visit; and using the same insulin during the last 1 month * hba1c ≥ 8.5% * subjects should routinely practice at least 2-4 blood glucose measurements per day * bmi ≤ 35 kg/m2 * subject must be able and willing to perform self-blood glucose monitoring and accept wearing a continuous glucose monitor for the total duration of the study * willing to complete a routine medical visits every 3 months * willing to complete a total of 7 phone visits * able to speak, read, and write english exclusion criteria: * on oral, inhaled or pre-mixed insulin * on symlin * bmi \> 35 kg/m2 * pregnant or intends to become pregnant during the course of the study * severe unexplained hypoglycemia that required emergency treatment over the past 3 months * history of hemoglobinopathies * diagnosis of anemia * hba1c greater than 12% * post-renal transplantation, currently undergoing dialysis, creatinine of \>1.5mg/dl or a calculated creatinine clearance of \<50 ml/min. * have extensive skin changes/diseases that inhibit wearing the sensor on normal skin * subjects who have a medical known allergy to adhesives * subjects who have an allergy to medication being used * currently participation in another investigational study protocol. must have completed a previous study at least 30 days prior to being enrolled in this one * have any condition that, in the opinion of the investigator, would interfere with their participation in the trial.

Keywords: diabetes mellitus type 1 diabetes glucose variability
impact of chromium, phyllanthus emblica, and shilajit on cardiovascular health, fitness, and weight loss during exercise and diet programs

Conditions: Overweight; Metabolic Syndrome X

Summary: a randomized, double-blind, placebo controlled, parallel study to determine if chromium (cr), phyllanthus emblica (pe) and shilajit (sj) supplementation and phyllanthus emblica fruit extract supplementation promotes greater changes in glucose homeostasis, endothelial function, and cardiometabolic risk in sedentary and overweight men and women initiating an exercise and weight loss program.

men and women with at least 2 markers of metabolic syndrome will participate in a randomized, placebo-controlled, parallel, and repeated measures intervention trial. volunteers will participate in a standardized resistance training (3 sessions/week) and aerobic training (3 x 30 min sessions/week) program while reducing energy intake by 5 kcals/kg/d. in a double-blind and randomized manner, participants will be matched by age, sex, bmi, and body mass to supplement their diet with placebo (pla), 400 mcg of trivalent chromium with 6 mg of pe and 6 mg of sj (cr-400), or 800 mcg of trivalent chromium with 12 mg of pe and 12 mg of sj (cr-800), or 500 mg of pe (pe-500), or 1000 mg of pe (pe-1000) once a day after breakfast for 12-weeks. fasting blood samples, dexa body composition, platelet aggregation, and ultrasound flow-mediated dilation (fmd) studies will be conducted at 0, 6, and 12 weeks of supplementation.

Eligibility criteria:
inclusion criteria: 1. sedentary males and females age 30-65 years with a bmi \>30 and/or percent body fat \>30% 2. medical clearance for participating in moderate to intense exercise training and testing; 3. meet the 2006 international diabetes federation criteria for central obesity (ethnicity specific waist circumference) and any two risk factors to metabolic syndrome (i.e., fasting triglycerides \> 150 mg/dl or treatment for high triglycerides, hdl \ 130 mmhg or dbp \>85 mmhg or treatment of previously diagnosed hypertension, blood glucose ≥ 100 mg/dl or previous diagnosis for type ii diabetes); 4. absence of limiting musculoskeletal injury that would prevent participation in a general fitness program; and, 5. has given voluntary, written, informed consent to participate in the study. exclusion criteria: participants will not be allowed to participate in the study if: 1. they currently take or have taken nitrous oxide or anti-inflammatory type supplements or medications within one month of the start of the study; 2. they have uncontrolled hypertension, triglycerides \>500 mg/dl, elevated ast and alt \> 3 times the upper limit, and serum creatinine \>1.5 mg/dl); 3. they do not receive medical clearance from their personal physician to participate in the study and exercise program; 4. they are pregnant or plan to become pregnant; and/or 5. they are unable to complete at least 90% of the training.
a study to evaluate self-esteem and relationships in males with erectile dysfuntion

Conditions: Erectile Dysfunction

Summary: to determine the improvement in the self-esteem domain score of the self-esteem/overall relationship (sear) questionnaire and the improvement in erectile function (obtained from the erectile function \[ef\] domain of the international index of erectile function \[iief\]). furthermore, to determine if the improvement obtained in self-esteem was related to the main erectile dysfunction (ed) co-morbidities type and/or number.


Eligibility criteria:
inclusion criteria: -men with a documented clinical diagnosis of ed confirmed by a sexual health inventory-male (shi-m) score of 21 or less and who have a sexual partner for the duration of the study were included. exclusion criteria: * subjects who have previously taken, or it is suspected they have taken, more than 4 doses of sildenafil citrate, or any other phosphodiesterase type 5 (pde-5) inhibitor, or apomorphine, at any time prior to the screening visit or patients who have taken any dose of these compounds in the last two months * subjects with resting sitting hypotension (bp \ 170/110mmhg) * subjects with significant cardiovascular disease, including cardiac failure, myocardial infarction, unstable angina, stroke or transient ischaemic attack (tia), symptomatic or clinically significant cardiac arrhythmias in the last 3 months * patients on nitrates.
early versus delayed cord clamping at term: outcomes in swedish infants

Conditions: Iron Deficiency; Neonatal Hyperbilirubinemia

Summary: delayed clamping of the umbilical cord might prevent or slow the onset of iron deficiency by increasing the infant's iron endowment at birth. compared with early clamping, a delay of around 2-3 min provides an additional 25-40 ml of blood per kg of bodyweight. the results of previous intervention studies on delayed clamping are mixed, and few followed up infants beyond the perinatal period. all longer follow up studies have been performed in low income countries. the main objectives, therefore, was to assess whether delayed cord clamping improves hematological and iron status at 4 respective 12 months of age in a large sample of full-term, swedish infants. the investigators also choose to investigate if the timing of clamping the umbilical cord could affect rate of infections during the first four months of life and to assess the infants development at 4 and 12 months of age.


Eligibility criteria:
inclusion criteria: * non-smoking mother * healthy mother (no hemolytic disease, no treatment with any of the following drugs: anticonvulsants, antidepressants, thyroid hormone, insulin, chemotherapy or cortisone), * normal pregnancy (no preeclampsia, no diabetes, no prolonged rupture of membranes or signs of infection) * single birth, term pregnancy (gestational age 37 +0 until 41 +6 weeks + days) * expected vaginal delivery with cephalic presentation * mother should be able to master swedish well enough to participate in the study * mother should live close enough to the hospital to be ready to return for follow up after four months. exclusion criteria: * serious congenital malformation, syndrome or other congenital disease that can affect the outcome measures

Keywords: umbilical cord cord clamping iron ferritin newborn jaundice infant development infections
a longitudinal outcomes study of the subchondroplasty® procedure in the foot/ankle

Conditions: Insufficiency Fractures; Stress Fracture; Stress Fracture, Ankle, Foot and Toes

Summary: post market clinical outcomes study to collect data on the short - and long-term outcomes for subjects who are undergoing or who have undergone the subchondroplasty procedure in the foot and/or ankle in a standard clinical setting. outcomes to be assessed include pain medication usage, pain, function, activity levels and patient satisfaction.

this is a post-market, multi-center, patient outcomes centered study to evaluate the on-label use of accufill during the subchondroplasty procedure (scp). enrolled subjects will sign an informed consent form, satisfy the inclusion/exclusion criteria and have at least one bone marrow lesion, such as a cyst or stress fracture confirmed by diagnostic imaging in the foot and/or ankle joint. demographics, medical history and medications will recorded at the time of enrollment. surgical details including the scp procedure, concomitant surgical procedures and intraoperative safety events will be recorded. subjects will complete validated patient reported outcomes measures pre-operatively including the foot function index (ffi) revised short form, the eq-5d™ and numeric pain score. these measures plus a subject satisfaction survey will also be administered post-operatively at 6 weeks, 3 months, 6 months, 1 year, and 2 years. screening for adverse events and revision surgeries will occur throughout the study. target enrollment is 140 patients at up to 25 clinical sites. subjects will complete the study at 2 years or will be withdrawn if the patient undergoes revision surgery of the subchondroplasty site.

Eligibility criteria:
inclusion criteria: * subject has at least one bone defect such as a bone marrow lesion (bml), cyst or stress fracture confirmed by diagnostic imaging * surgeon considers the patient appropriate for the scp procedure * subject provides voluntary signature on the institutional review board (irb) approved informed consent * subject is at least 18 years of age * subject must be physically and mentally willing and able, in the investigator's opinion at the time of enrollment, to complete outcome forms via the internet, telephone or regular mail exclusion criteria: * subject is pregnant at the time of surgery * subject is incarcerated * subject is involved in active litigation related to the condition being treated

Keywords: bone marrow defect bone marrow lesion stress fracture calcium phosphate bone substitute material
prediction of acute kidney injury after operation of acute type a aortic dissection based on multimodal model

Conditions: Aneurysm, Dissecting; Acute Kidney Injury

Summary: acute kidney injury is one of the most common postoperative complications of acute type a aortic dissection, which is closely related to early postoperative death. early prevention, early diagnosis and early treatment are the key to improve the prognosis of such patients. it has been a hot topic in clinical research for a long time. previous reports revealed a series of risk factors for acute kidney injury after aortic dissection, but limited by research design and single modal data, high quality studies were rare. the purpose of this study is to further clarify the risk factors by studying the relationship between preoperative ct renal perfusion imaging indexes and postoperative acute kidney injury; establish and externally verify the multimodal radiomics prediction model for acute kidney injury after operation of aortic dissection combining with preoperative ct renal perfusion imaging and ct angiography information by analysis methods of information fusion, feature engineering and radiomics, so as to guide the follow-up clinical practice, improve the prognosis of such patients and save medical resources.


Eligibility criteria:
inclusion criteria: 1. 18-70 years old 2. acute type a aortic dissection diagnosed by ct angiography 3. sign informed consent exclusion criteria: 1. history of chronic kidney disease 2. history of cardiovascular operation 3. acute kidney injury has occurred before operation 4. pregnancy status